Overview

This trial is active, not recruiting.

Condition pain
Treatments methadone, methadone and morphine
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Start date March 2005
End date March 2016
Trial size 70 participants
Trial identifier NCT00142519, 05-025

Summary

This is a randomized Phase II study testing the effectiveness of the combination of morphine and methadone versus morphine alone in relieving pain. A second goal is to further evaluate any side effects of the combination of morphine and methadone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
methadone
methadone
Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg
(Experimental)
methadone and morphine
methadone and morphine
Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg

Primary Outcomes

Measure
The primary goal of this study is to compare the analgesic effects of a combination of morphine and methadone with morphine alone to determine synergistic activity of mu opioid analgesics in patients with post-operative pain.
time frame: Time to the third request for the pain medication

Secondary Outcomes

Measure
To determine if there are any side effects from the combination of morphine and methadone when given together.
time frame: assessed every 10 minutes

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Retroperitoneal lymph node dissection - Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every 10 minutes - 18 years of age or older - English-speaking - Give informed consent to participate in this study Exclusion Criteria: - Known hypersensitivity to methadone or morphine - Patients with past or present history of substance abuse - Patients with a history of methadone treatment - Patients with a history of chronic pain requiring daily analgesic use for more than 3 months - Patients treated with opioids within one month from the scheduled surgery - Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation). - Neurologic or psychiatric disease sufficient, in the doctor's opinion, to compromise data collection

Additional Information

Official title Translational Studies in Analgesic Pharmacology: Analgesic Synergy in Clinical Pain. A Phase 2 Study Comparing a Single Dose of a 1:1 Combination of Methadone and Morphine With Morphine Alone in Patients With Post-operative Pain.
Principal investigator Natalia Moryl, MD
Description Rationale: Experimental data demonstrates a profound analgesic synergy between morphine and methadone when co-administered systemically in mice. If this type of synergy can be demonstrated in clinical pain, it will be a relatively unique example of translating concepts of fundamental aspects of opioid actions seen in the laboratory to the clinical area, and provide a basis for offering new and scientifically- based analgesic regimens. This may provide better pain relief with less opioid related side effects in clinical practice. Purpose: This is a randomized, double blind, parallel arm Phase II study comparing a single dose of 1:1 combination of methadone and morphine with morphine alone in patients with post-operative pain. - The primary objective of this randomized, double blind, parallel arm Phase II study is to compare the analgesic effects of a combination of morphine and methadone with morphine alone to determine synergistic activity of mu opioid analgesics in patients with post-operative pain. - A second goal is to further evaluate any side effects of the combination of morphine and methadone.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.